Kornimate/medical-research-clean huggingface dataset:
plastic wound retractors and bacterial translocation in abdominal surgery

Conditions: Bacterial Translocation; Surgical Site Infection; Abdominal Surgery; Wound Infection

Summary: hypothesis: plastic wound retractors reduce passage of bacteria from the abdomen to the surgical incision site in abdominal surgery currently, plastic wound retractors are used in abdominal surgery to facilitate access to the abdominal cavity. this study aims to establish whether they also prevent bacteria crossing from the abdominal cavity to the surgical incision site. patients undergoing abdominal surgery in which a plastic wound retractor (alexis®)is used are eligible for inclusion in the study. swabs are taken from the inside and the outside of the plastic wound retractor prior to removing the retractor from the abdomen. the bacterial flora from swabs taken inside and outside the plastic wound protector are then compared to see if there is any difference between inside and outside the retractor. bacteria are classified as 'enteric'(i.e. from the gastrointestinal tract) or 'skin' bacteria, depending on their usual location. the study aims to establish whether a plastic wound retractor (alexis®) reduces translocation of enteric bacteria to the surgical incision site.

plastic wound retractors are currently used in abdominal surgery for wound retraction. they allow access to intra-abdominal organs through an incision in abdominal surgery. plastic wound retractors may also act as a barrier to bacterial translocation from the abdominal cavity to the wound. the purpose of this study was to compare microbial flora from inside and outside the plastic wound retractor to establish whether plastic wound retractors affect bacterial translocation. methods this multi-centre prospective observational study is being conducted between november 2007 and january 2010. patients undergoing elective or emergency abdominal surgery in which an alexis® wound retractor is used are eligible for inclusion in the study. swabs are taken from inside and outside the alexis® wound protector immediately prior to removal of the wound protector from the abdominal cavity. swabs undergo gram stain and culture. "inside" the wound swab is defined as the part of the wound protector in contact with the intra-abdominal organs, "outside" is the part in contact with the skin and subcutaneous tissues. results from inside and outside swabs are then compared to establish whether there is a difference in bacterial flora. the study aims to establish whether a plastic wound retractor (alexis®) reduces translocation of enteric bacteria to the surgical incision site.

Eligibility criteria:
inclusion criteria: * patients undergoing abdominal surgery in which a plastic wound retractor is used exclusion criteria: * n/a

Keywords: plastic wound protector plastic wound retractor bacterial translocation surgical site infection abdominal surgery wound infection
evaluation of the prevalence and clinical manifestation of sars-cov-2 infection in a population of adult and pediatric patients with congenital heart disease

Conditions: Congenital Heart Disease; Cardiomyopathy; Pulmonary Arterial Hypertension; SARS CoV-2 Infection

Summary: the goal of this observational study, drug-free, cross-sectional, single-center is to describe the incidence and characteristics of the clinical course and any short- and medium-term complications of patients with congenital heart disease of medical interest, and pediatric patients with cardiomyopathy, arrhythmic pathology or pulmonary arterial hypertension who have been affected by sars-cov-2 disease. the secondary objective of the study is to identify risk factors for the development of moderate-severe forms of covid-19 disease in the study population.

this is an observational, drug-free, cross-sectional, single-centre study. all patients followed at our centre and suffering from congenital heart disease treated with only haemodynamic procedures haemodynamic procedures alone, as well as paediatric patients suffering from cardiomyopathy, pulmonary hypertension or arrhythmic pathology whose follow-up was still in progress at the time of the start of the pandemic (due to death or for reasonsof the patient). the structural collection of data necessary for the evaluation of targets will take place through the creation of a specific electronic archive, in which census of all patients who have undergone follow-up at our centre since 01/01/2005 at the time of study approval and still in follow-up at the time of the start of the pandemic. patients of all ages will be enrolled age, both paediatric and adult, followed at our centre. it is estimated to include in the study approximately 5000 patients.

Eligibility criteria:
inclusion criteria: * patients of all ages with congenital heart disease undergoing hemodynamic procedures at our center or in natural history * pediatric patients with cardiomyopathy, arrhythmic disease, or hypertension pulmonary * obtaining informed consent * patients who have access to an e-mail address and a computer to complete the questionnaire exclusion criteria: * patients with congenital heart disease undergoing corrective or palliative surgical treatment
intracavernous bone marrow stem-cell injection for post prostatectomy erectile dysfunction

Conditions: Prostate Cancer; Erectile Dysfunction

Summary: erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer. it is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction. bone marrow mononucleated cells (bmmnc) contain different cell types that may replace the damaged penile cells after radical prostatectomy. these are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. intracavernous injection of bmmnc may therefore find application in the treatment of post prostatectomy erectile dysfunction. the aims of this phase i-ii study is to test the safety of autologous intracavernous bmmnc injection and to evaluate benefit for the patient concerning recovery of natural erection. patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study. four different doses of bmmnc will be tested.

we have shown in a rat model of post prostatectomy erectile dysfunction that bmmnc injection replace apoptotic cavernous cells and restore erectile function. in the pig, the injection of high dose of bmmnc into the corpus cavernosus does not cause side effect. moreover, the bmmnc remains at the injection site.

Eligibility criteria:
inclusion criteria: * localized prostate cancer: psa (prostate specific antigen) prior to radical prostatectomy \< 10 ng/ml, histopathologic analysis of the prostate showing a prostate cancer with gleason score ≤ 7, negative margin, absence of effraction of the prostatic capsule, pt1 or pt2 n0 or nx. * psa=0 ng/ml 6 months after radical prostatectomy. * normal erectile function prior to radical prostatectomy. * penile arterial insufficiency and or venous leakage (doppler) at the time of inclusion: psv \ 25 cm/sec, edv\>5cm/sec, ri\<0,75. exclusion criteria: * non localized prostate cancer.

Keywords: radical prostatectomy
corona germany- clinical outcome and risk in hospitalized covid-19 patients - an epidemiological study from germany

Conditions: COVID-19

Summary: this is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in germany, all part of a german hospital network. all hospitalized patients tested positive for sars-cov-2 will be included.

corona germany is a multicenter, observational, prospective, epidemiological cohort study at 45 hospitals in germany, all part of a german hospital network. from january 1st till november 17th, 2020, all hospitalized patients tested positive for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) will be included. demographical data and outcomes will be assessed in the entire study cohort. in a subgroup, consisting of 7 hospitals, further detailed data (e.g. baseline characteristics, laboratory values, medication, clinical events) will be assessed. additionally, there will be subgroups of patients with cardiovascular events and prior or preexisting oncological diseases. there are two primary endpoints: 1. combination of all-cause death and/or need for mechanical ventilation and/or allocation to intensive care unit (icu). 2. occurrence of a clinical manifest cardiovascular events. the aim of the study is the development of a prediction model for the primary endpoints, whereas the secondary endpoint is a comparison of mortality rates between the 1st (01/01/20-09/15/20) and 2nd (15/09/20) infection wave. all endpoints will be verified by an endpoint review committee. a steering committee, consisting of representatives of the 45 hospitals, the trial statistician and members of the scientific department, takes responsibility of the study design and results.

Eligibility criteria:
inclusion criteria: * hospitalized patients tested positive for sars cov-2 using a reliable test method (mostly polymerase chain reaction test) exclusion criteria: * patients with negative sars cov-2 testing

Keywords: covid-19 corona risk factor sars-cov-2
cooling anesthesia for intravitreal injection

Conditions: Anesthesia, Local; Intravitreal Injection; Macular Degeneration; Diabetic Macular Edema

Summary: the purpose of this clinical study is to evaluate the safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device and determine the effects of temperature and duration of application on subjective pain after intravitreal injection.

intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema. there is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia. recens medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye this device cools to a temperature around -5 to -10 degrees celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. the value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections. this device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care. this dose escalation study will test various temperatures and duration of temperatures to evaluate for safety as well as determine the optimal temperature for anesthesia during intravitreal injection.

Eligibility criteria:
inclusion criteria: * men and women \> 18 years old at screening visit. * men and women who are undergoing intravitreal injections in either one eye or both eyes with either lucentis or eylea as part of their normal standard of care with a 30 gauge needle. * subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit. * subject is willing and able to sign the study written informed consent form (icf). exclusion criteria: * history of presence of scleromalacia * preexisting conjunctival, episcleral or scleral defects * less than 18 years of age * unable to provide informed consent * has received less than 3 injections in the study eye * active severe eye disease not controlled with artificial tears and requiring restasis or xiidra drops. * history of endophthalmitis with intravitreal injection * history of uveitis * history of retinal detachment in either eye * history of vitrectomy

Keywords: intravitreal injection anesthesia macular degeneration diabetic macular edema
effect of an adult education program on cardiovascular outcomes in post-myocardial-infarction patients

Conditions: Myocardial Infarction

Summary: a non-md-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (stemi and nstemi), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors.. the intervention arm will be compared to a control group of patients treated with usual care.


Eligibility criteria:
inclusion criteria: * history of acute st-elevation myocardial infarction (stemi) or non-st-elevation myocardial infarction (nstemi), type ι, according to the 3rd universal definition of mi, within the preceding 6 weeks * absence of substantial cognitive dysfunction (mini mental state examination score ≥24) exclusion criteria: - age \>80 years or \<18 years
the role of c-ham in the surgical repair of peroneal tendons: an infrared thermography model

Conditions: Tendon Tears

Summary: peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. like all flexor tendon repairs adhesions are one of the more common challenges after surgery. peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (adzick 1994). our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. a prospective review on the surgical repair of the peroneal tendons utilizing clarix™1k (amniox medical, marietta, ga), cryopreserved human amniotic membrane (c-ham) graft will be performed. the investigators hypothesize that the use of cryopreserved human amniotic membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.


Eligibility criteria:
inclusion criteria: 1. patients requiring surgical repair of the peroneal tendon 2. patients who voluntarily consent to research participation 3. patients over the age of 18 exclusion criteria: 1. patients who display a high surgical risk as determined by the investigative surgeon 2. previous surgical repair of the peroneal tendon less than 2 years prior to surgery 3. peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion 4. patients with allergy or history of drug reactions to ciprofloxacin or amphotericin b 5. patients who are pregnant or breast feeding. 6. patients who have had a clinically diagnosed autoimmune disease 7. patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg qd for dvt prophylaxis during the postoperative immobilization period 8. patients with an active infection 9. patients who have a medical history that would likely make the patient an unreliable research participant 10. patients requiring surgical repair of the peroneus longus tendon

Keywords: peroneal tendon
plasticity of grey and white matter in response to motor skill training in healthy individuals and those with spinal cord injury

Conditions: Investigating Spinal Atrophy in Patients With Spinal Injury

Summary: we aim to investigate the effect of motor skill training of the upper and lower limbs on the function and structure of the cns as measured by neuroimaging parameters sensitive to changes in tissue volume and density and the properties of myelin.

functional recovery following human spinal cord injury (sci) remains frustratingly limited and the majority of patients are left with severe impairments. while rehabilitative training has been shown to improve clinical outcome following sci and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood. until recently, degenerative changes in components of the cns remote to a sci were thought to occur slowly (over years) and correlate with the degree of disability. using longitudinal mri protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (freund et al 2013). it is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (cst) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. crucially, patients with less atrophy throughout the cst were those with better clinical recovery at twelve months. despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.

Eligibility criteria:
inclusion criteria: patients: * injury to the spinal cord which leads to any neurological deficits * able to provide informed consent controls: - able to provide informed consent exclusion criteria: * pregnancy * mri incompatible * neurologic or physiatric disorders
jkb-121 for the treatment of nonalcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis

Summary: to evaluate the safety and potential efficacy of two dose levels of jkb-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis

jkb-121 is a long-acting small molecule that is efficacious as a weak antagonist at the tlr-4 receptor. it is a non-selective opioid antagonist which has been shown to prevent the lipopolysaccharide (lps) induced inflammatory liver injury in a methionine/choline deficient diet fed rat model of nonalcoholic fatty liver disease. in vitro, jkb-121 neutralized or reduced the lps-induced release of inflammatory cytokines, deactivated hepatic stellate cells, inhibited hepatic stellate cell proliferation, and collagen expression. inhibition of the tlr4 signaling pathway may provide an effective therapy in the prevention of inflammatory hepatic injury and hepatic fibrosis in patients with nonalcoholic steatohepatitis. this study will evaluate the safety and potential efficacy of two dose levels of jkb-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. provision of written informed consent 3. biopsy-proven nash within 12 months or at screening 4. alt \> 40 u/l for women and \> 60 u/l for men at screening and at least once in the previous 12 months. 5. hba1c of ≤ 9.0 exclusion criteria: 1. any chronic liver disease other than nash 2. cirrhosis, as assessed clinically or histologically 3. presence of vascular liver disease 4. bmi ≤ 25 kg/m2 5. excessive alcohol use (\> 20 g/day) within the past 2 years 6. ast or alt \> 250 u/l. 7. type 1 diabetes mellitus 8. bariatric surgery in the past 5 years. 9. weight gain of \> 5% in past 6 months or \> 10% change in past 12 months. 10. contraindication to mri 11. inadequate venous access 12. hiv antibody positive, hepatitis b surface antigen positive (hbsag), or hepatitis c virus (hcv) rna positive. 13. receiving an elemental diet or parenteral nutrition 14. chronic pancreatitis or pancreatic insufficiency 15. any history of complications of cirrhosis 16. concurrent conditions: * inflammatory bowel disease * significant cardiac disease * chronic infection or immune mediated disease * any malignant disease * prior solid organ transplant * any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data. 17. concurrent medications which may treat nash 18. hba1c \> 9.0% 19. pregnancy or breastfeeding.
turkish version of fear of falling avoidance behavior questionnaire

Conditions: Fall; Fear; Older People

Summary: this study is planned to translate the fear of falling avoidance behaviour questionnaire (ffabq) into turkish and to assess the psychometric properties (validity, reliability, responsiveness, floor and ceiling effect) of this turkish version.

the permission for the turkish version was received by landers. the translation will be made according to beaton et al. guidelines. the internal reliability of the ffabq türkish version will be assessed using cronbach's alpha, and item analyses will be conducted by examining the effect on cronbach's alpha of excluding each of the six fog-q items individually. the test-retest reliability will be assessed using intraclass correlation coefficient (icc). convergent validity will be evaluated by means of spearman rank correlation coefficient (rs). in this section will be determined the correlation between the activities-specific balance confidence scale and visual analog scale for fear of falling.

Eligibility criteria:
inclusion criteria: * having good cognitive functions (standardized mini mental test score of 24 and above) * to be able to live independently in the community, * to voluntarily participate exclusion criteria: * the use of drugs that may affect balance * polypharmacy status * having serious musculoskeletal or neurological disorders, * lower or upper limb amputation that may affect balance.